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Job Information

Merck Principal Scientist - Large molecule critical reagents and reference standards in Rahway, New Jersey

Job Description

Large Molecule Analytical Validation group within Analytical Research & Development, our company's Research Labs is seeking a motivated Principal Scientist with technical expertise in developing large molecule critical reagent strategies. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of analytical, regulatory and quality disciplines to enable robust commercial testing. More specifically, the ideal candidate will be a recognized expert developing reference standard and critical reagents based on mechanistic understanding of large molecule analytical methods. The successful candidate is expected to provide scientific expertise, and creativity to solve complex situations across the portfolio. They will be accountable to inspire and cultivate scientific rigor through implementation of innovative technologies and approaches to enable efficient critical reagent management in the program’s life cycle.

The ideal candidate will provide technical and scientific leadership to a group of 3-5 individuals, to support the robust large molecule pipeline. Responsibilities include representing the group on product development teams, defining and implementing large molecule critical reagent strategy, oversight of reagent qualifications/ testing, documentation, and scientific mentoring. The candidate will be expected to effectively communicate with management, governance teams, and stakeholders across the organization.

Education Requirements:

  • Ph.D. in biological science, biochemistry, molecular biology, cell biology, virology with a minimum of 8 years of relevant biopharmaceutical industry experience OR M.S. with a minimum of 10 years of relevant experience

Required Skills and Experience:

  • In-depth knowledge and understanding of analytical development, technical knowledge of potency assays reflective of mechanism-of-action, and immunoassays used in the development of biologics and vaccine products.

  • Strong leadership skills, team spirit, and a passion for mentoring with effective organizational and multi-tasking ability.

  • Demonstrated ability to interpret complex experimental designs and detailed data analysis concepts related to analytical method validations and reagent qualification/ re-evaluations.

  • Experience with monitoring reagent/ assay performance and control for drifts in key quality attributes between and within reference standards, and analytical bridging studies.

  • Deep working knowledge of regulatory guidance and quality standards, with experience devising reference standard strategy for large molecules (Vaccines and Biologics including therapeutic proteins, monoclonal antibodies, Antibody-drug conjugates). Candidates should have experience with authoring and reviewing regulatory submissions, and prior Health Authority engagements (e.g. Biologics license application submission).

  • Demonstrated scientific track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration, with superior written and oral communications skills.

  • Experience with external scientific community, publications, regulatory guidance documents, industry white paper contributions, presentations at scientific meetings, and/or membership on (or leading) cross-company working groups or consortia.

  • Ability to navigate through evolving program needs via informed, rapid decision making, mentoring of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.  

#AR&D

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$149,400.00 - $235,100.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/10/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 08/10/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R301389

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